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Trial registered on ANZCTR


Registration number
ACTRN12615000720516
Ethics application status
Approved
Date submitted
29/06/2015
Date registered
13/07/2015
Date last updated
27/05/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Non-Invasive Brain Stimulation: the Influence of Gender and Menstrual Phase
Scientific title
An Investigation of the Impact of Gender and the Menstrual Cycle on the Effects of tDCS and rTMS on Cortical Excitability in Healthy Controls.
Secondary ID [1] 286985 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy human volunteers 295442 0
Condition category
Condition code
Mental Health 295693 295693 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will either take part in the transcranial direct current stimulation (tDCS) or repetitive transcranial magnetic stimulation (rTMS) rTMS arms of the study. They will not be required to engage in both.

tDCS study arm: 1 mA tDCS. The anodal stimulation will be applied to the left dorsolateral prefrontal cortex and the cathode over the right orbit. Stimulation will be delivered for for 15 minutes using a neuroConn GBH/Eldith DC stimulator.

rTMS study arm: Fifty trains of 10 Hz rTMS delivered at 120% of resting motor threshold. rTMS will be delivered using the MagPro R30 to the left DLPFC. Trains will be 4.5 second in duration with a 20.5 second inter-train interval (2250 pulses over 20.8 minutes).

Males will take part in one testing session only. Females will take part in two testing sessions: once during an early phase of the menstrual cycle when endogenous estrogen is low, and once more during a later phase when endogenous estrogen level are high.
Intervention code [1] 292198 0
Treatment: Devices
Comparator / control treatment
The study is a comparison of cortical excitability between male and female adults, and within the female cohort of high and low estrogen phases of the menstrual cycle.

Changes in cortical excitability will be compared within the TMS and tDCS arms of the study, but not between the two techniques.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 295412 0
For both arms of the study, the amplitude of pre vs post stimulation cortical evoked potentials measured from the DLPFC.

Single pulse TMS/EEG will be used to measure cortical evoked potentials.
Timepoint [1] 295412 0
Cortical evoked potential amplitude 20-minutes following stimulation, relative to pre-stimulation.
Secondary outcome [1] 315725 0
For both arms of the study, the amplitude of pre vs post stimulation cortical evoked potentials measured from the DLPFC.

Single pulse TMS/EEG will be used to measure cortical evoked potentials.
Timepoint [1] 315725 0
Cortical evoked potential amplitude immediately following stimulation, relative to pre-stimulation.

Eligibility
Key inclusion criteria
1. Are voluntary and competent to consent,
2. Are right handed ,
3. Have no history of endocrine disorder, traumatic brain injury or neurological or mental illness.
Minimum age
18 Years
Maximum age
40 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
General Exclusion Criteria:

1. Are a professional driver,
2. Have epilepsy or a history of seizure,
3. Currently taking any psychoactive medications,
4. Have metal anywhere in the head, except the mouth. This includes metallic objects such as screws and slips from surgical procedures.

Female Specific Exclusion Criteria

1. Are currently pregnant or lactating,
2. Currently taking the oral contraceptive pill,
3. Have an irregular menstrual cycle.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 291547 0
University
Name [1] 291547 0
Monash University
Address [1] 291547 0
Wellington Rd
Clayton, VIC
3168
Country [1] 291547 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Wellington Rd
Clayton, VIC
3168
Country
Australia
Secondary sponsor category [1] 290224 0
None
Name [1] 290224 0
Address [1] 290224 0
Country [1] 290224 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293089 0
Alfred Health Human Ethics Committee
Ethics committee address [1] 293089 0
Alfred Health Human Ethics Committee
Alfred Hospital
Commercial Rd
Prahran
3181 VIC
Ethics committee country [1] 293089 0
Australia
Date submitted for ethics approval [1] 293089 0
Approval date [1] 293089 0
26/05/2014
Ethics approval number [1] 293089 0
129/14

Summary
Brief summary
Non-invasive brain stimulation is emerging as a therapeutic tool for many brain related conditions. There are numerous non-invasive brain stimulation techniques that apply electrical or electromagnetic stimulation to the brain in different ways to alter neural activity. The most researched, and consequently best developed, of these are transcranial magnetic stimulation (TMS) and transcranial direct current stimulation (tDCS). Both TMS and tDCS has been shown to have varying degrees of therapeutic efficacy for major depression. Research efforts are currently focused on identifying factors that modulate individual differences in the way the brain response to TMS which could lead to development of optimised protocols for stimulation delivery.

There is evidence that sex hormones may modulate the effect of TMS and tDCS. However very few studies have investigated this and none have focused on the dorsolateral prefrontal cortex, the site that both methods are most often applied in a clinical context. The current project is an investigation of the impact of gender, and within female gender of menstrual phases associated with high and low estrogen, on the effect of TMS and tDCS to the dorsolateral prefrontal cortex.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 58386 0
Dr Rebecca Segrave
Address 58386 0
Monash Alfred Psychiatry Research Centre Level 4, 607 St Kilda Rd Prahran VIC 3181
Country 58386 0
Australia
Phone 58386 0
+61 3 9076 5030
Fax 58386 0
Email 58386 0
rebecca.segrave@monash.edu
Contact person for public queries
Name 58387 0
Ms Cassandra Thomson
Address 58387 0
Monash Alfred Psychiatry Research Centre Level 4, 607 St Kilda Rd Prahran VIC 3181
Country 58387 0
Australia
Phone 58387 0
+61 3 9076 6592
Fax 58387 0
Email 58387 0
cassandra.thomson@monash.edu
Contact person for scientific queries
Name 58388 0
Dr Rebecca Segrave
Address 58388 0
Monash Alfred Psychiatry Research Centre Level 4, 607 St Kilda Rd Prahran VIC 3181
Country 58388 0
Australia
Phone 58388 0
+61 3 9076 5030
Fax 58388 0
Email 58388 0
rebecca.segrave@monash.edu

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary